Device for applying selective and general hypothermy to and reheating of human body through the common integuments thereof

ABSTRACT

A DEVICE IS PROVIDED FOR APPLYING SELECTIVE AND GENERAL HYPOTHERMY TO AND REHEATING OF A HUMAN OR ANIMAL BODY THROUGH THE COMMON INTEGUMENTS THEREOF, THE DEVICE BEING PROVIDED WITH HOLLOW ELEMENTS MADE IN A SHAPE CORRESPONDING TO THAT OF THE BODY SURFACE TO BE TREATED. A HEAT-TRANSFER MEDIUM IS SUPPLIED TO THE HOLLOW ELEMENTS WHICH ARE DISPOSED ON THE SIDE FACING THE BODY SURFACE UNDER TREATMENT AND ARE PROVIDED WITH OPENINGS FACING THE BODY SURFACE TO ALLOW HEAT-TRANSFER MEDIUM TO EMERGE IN UNIFORMLY DISTRIBUTED JETS AT RIGHT ANGLES ONTO THE SURFACE BEING TREATED.

United States Patent lnventors Oleg Alexandrovich Smirnov ulitsoSolyanlm, H2, .20;

Viktor Petrovich Danllov, ulitsa 3 Parkovaya, $2, korpns l, kv. 23,Moscow; Vyacheslnv Ivanovich Znbkov, Rnmensky ralon, poselok llinskoe,ulitsa Vtoraya Lesnaya, 33, Moskovskaya oblast, U.S.S.R. 17,030

Mar. 9, 1970 June 28, 1971 Continuation of application Ser. No. 614,262,Feb; 6, 1967, now abandoned.

Appl. No. Filed Patented DEVICE FOR APPLYING SELECTIVE AND GENERALHYPOTHERMY TO AND REHEATING OF HUMAN BODY THROUGH THE COMMON INTEGUMENTSTHEREOF 6 Claims, 3 Drawing Figs.

US. Cl 128/254, 128/402,4/l59 Int. Cl. A61! 7/00 Field of Search.128/254, 256, 258, 260, 248, 65, 66, 379, 380, 400, 402;

References Cited UNITED STATES PATENTS 5/1886 1.61161 998,804 7/1911Salisbury 4/159 1,847,619 3/1932 MaSCOlO... 128/254 2,566,600 9/1951Colon 128/65 2,726,658 12/1955 Chessey 128/400 2,854,969 10/1958 Nolan128/65 2,914,066 11/1959 GOW 128/66 3,088,459 5/1963 Rabinotf 128/663,091,242 5/1963 .lohnson,Jr.etal. 128/402 3,272,201 9/1966 Burns 128/66FOREIGN PATENTS 685,816 4/1930 France 128/66 528,292 6/1931 Germany...4/159 1,022,767 1/1958 Germany 132/9 Primary Examiner-Richard A. GaudetAssistant Examiner-Ronald L. Frinks Attorney-Waters, Roditi, Schwartzand Nissen ABSTRACT: A device is provided for applying selective andgeneral hypothermy to and reheating of a human or animal body throughthe common integuments thereof, the device being provided with hollowelements made in a shape corresponding to that of the body surface to betreated. A heattransfer medium is supplied to the hollow elements whichare disposed on the side facing the body surface under treatment and areprovided with openings facing the body surface to allow heat-transfermedium to emerge in uniformly distributed jets at right angles onto thesurface being treated.

PATENTH] JUN28 197i SHEET 1 [1F 2 DEVICE FOR APPLYING SELECTIVE ANDGENERAL HYPOTHERMY TO AND REHEATING OF HUMAN BODY THROUGH THE COMMONINTEGUMENTS THEREOF This application is a continuation of priorcopending application Ser. No. 614,262, filed Feb. 6, 1967, nowabandoned.

This invention relates to devices used for both selective and generalhypothermy applied to human or animal body through the commoninteguments thereof, use of such devices being preferably made inmedical practice for rendering bodily tissues e.g., the brain moreendurable to oxygen deficiency (anoxia), in surgical operations on anopen heart without applying an artificial blood circulation apparatus,as well as in craniocerebral surgery, for local cooling of extremitiesaffected by thrombosis of arteries, for treating complications resultingfrom acute anoxia of tissues, for eliminating hypothermy of the body,and in some other cases.

Known in the art are devices for performing selective and generalhypothermy applied to man or animal through the common integumentsthereof, wherein a heat-transfer agent while circulating inside hollowelements located nearby the surface of the patient's body, is capable ofthermal interaction or interchange therewith through the walls of saidhollow elements (cf. Great Medical Encyclopedia, 2nd edition, vol. 7, p.243).

The aforementioned devices are made as blankets (thermosuits") providedwith double walls where between the heattransfer agent is circulating.Having passed through the "thermosuit" the heat-transfer agent passes tothe heat-exchanger of a refrigerating machine for subsequent reuse.

The device described above, however, suffers from the disadvantage thatthe heat exchange process between the patients body and the thermosuit"proceeds slowly which results in that the necessary level of generalhypothermy is attained only in l or 2 hours whereas an isolated highhypothermy of the brain cannot be obtained at all.

By making use of apparatus for artificial blood circulation one canquickly lower or raise the temperature of the whole body or of a certainpart thereof, e.g. the head.

However, a number of disadvantages are inherent in the aforesaidapparatus which reside in the fact that some 5 liters of donor's bloodand blood substitutes are needed for their functioning, the blood to beused should necessarily be rendered incoagulable with heparin; moreover,the application of said apparatus oftentimes leads to some complicationsoccurring in the patient being treated, such as haemolysis,thrombocytopenia, fibrinogenopenia, disturbance of electrolytic balanceof the organism, embolism, as well as variation in the vascular tonus.Furthermore, the known apparatus for artificial blood circulation failto be applied in emergency cases on account of great technologicaldifficulties offered thereto.

Some other applicances made use of heretofore for reducing thetemperature of the human body, such as cold baths, ice bags, and thelike are bulky, difficult in use, unreliable, hard to control and needmuch time to attain the required level of hypothermy.

It is an object of the present invention to eliminate theabove-mentioned disadvantages.

It is another object of the present invention to obtain both selectiveand general hypothermy not only under stationary conditions (at aninflrmary) but in a first aid service, too.

It is likewise an object of the present invention to provide such adevice that would be capable not only of cooperating with arefrigerating machine but be operative from a source of heat or coldwhich makes use of a heat-transfer fluid possessing the necessarytemperature and fed at the required pressure.

It is a further object of the present invention to obtain a highselective hypothermy e.g., of the cerebral cortex, the temperature ofthe rest of the body being maintained at the desired level.

It is a specific object of the present invention to provide a device forboth selective and general hypothermy of man or animal applied to thecommon integuments of the body or of any part thereof, e.g., of thehead, by means of a heatexchange device which is capable of effectivethermal interaction or interchange between the surface of the livingbody being treated and the heat-transfer fluid, enables the surfaceunder treatment to be kept under visual observation and be accessiblefreely.

Said object is accomplished due to the fact that the present device isgiven a shape approximating the shape of that part of the body which isto be treated with said device, whereas hollow elements thereof, ontheir effective side facing the body in the course of heat exchange, areprovided with openings for the heat-transfer fluid to emerge indistributed jets which are capable of directly acting upon the bodysurface being treated, preferably at right angles thereto, whereby aforced convective heat exchange is attained.

It is advantageous that in the present device the hollow elements bespaced somewhat apart from one another so as to gain free andunobstructed access to the surface being treated and. to keep it undervisual observation. Apart from this, such an arrangement contributes toa more effective heat exchange between the heat-transfer fluid and thepatients body since the former is rapidly taken off the surface beingtreated.

Provision is also made in the proposed device for projections located onthe side facing the surface being treated in the course of the heatexchange process so as to provide some gap between the device and thesurface involved and, consequently, to obtain jets of a present length.

For the purpose of greater economy in operation of the proposed deviceas well as for reusing the heat-transfer fluid by reiterativecirculating through the device, the latter comprises a receiver orheader for the heat-transfer fluid, said receiver or header beinglocated on the side opposite to the surface under treatment and beingpreferably made from a material possessing low thermal conductance.

Given below is a description of the present invention and exemplaryembodiments thereof with due reference to the accompanying drawings,wherein:

FIG. I is a side diagrammatic view of the device for applying hypothermyto and reheating of the human brain through the common integument of thehead, as made of tubes according to the invention;

FIG. 2 illustrates inside elevation an alternative design of said devicefeaturing a space formed by two hemispheres made of a synthetic materialfor the heat-transfer fluid to pass;

FIG. 3 shows said device when connected to a source of cold (or heat)provided with an automatic control system of a cooling or heatingprocess.

In the description of the particular embodiments of the inventiondisclosed hereinabove, specific narrow terminology has been resorted tofor the sake of clarity. It should be understood, however, that thepresent invention is in no way limited to the specific terms so selectedand that each such term covers all equivalent elements operating in asimilar manner and employed for solving similar problems.

Referring to the drawings, the device for hypothermy and reheating ofthe human brain comprises, according to the invention, hollow elementsi.e. tubes 1 (FIG. 1), a header 2, a pipe union 3 and a connecting hose4 (FIG. 3) through which the heat-transfer fluid is fed to the device.

The tubes 1 on their side facing the surface being treated, are providedwith openings 5 (FIG. 1) wherefrom the heattransfer fluid emerges, and afew projections 6 made as limiting lugs or bosses whereby a gap'betweenthe inner surface of the device and the surface of the patient's head isobtained. The tubes 1 are spaced somewhat apart from one another.

In an alternative embodiment of the invention the present device iscomposed of two hemispheric elements 7 and 8 (FIG 2) which are made froma synthetic material.

Provision is likewise made on the top of said device for the pipe union3 whereto the heat-transfer fluid feed hose is connected. A hemisphere 7which in the course of the heat exchange process faces the patient'shead, is provided with the openings 5 for the heat-transfer fluid toemerge, and with a few projections 6 by which the requisite gap betweenthe inner surface of the device and the surface of the heat is attained.To make the surface being treated freely accessible and visuallyobservable as well as for unobstructed removal of the heattransferfluid, provision is made in the proposed device for slits 9.

Represented in FIG. 3 is a schematic diagram showing the connection ofthe device for selective hypothermy and reheating of the human brainthrough the common integument of the head, to a source of cold (or heat)provided with an automatic control system for the cooling or heatingprocess. As can be seen from the FIG, the hose 4 with one of its endscommunicates through the pipe union 3 with the header 2 while with theother end of said hose is connected to the source of cold or heat, vizlarefrigerating unit provided with a heat-exchanger or a bank ofsemiconductor thermoelectric generators 10. The heat interchanger or thebank of thermogenerators 10 is connected to a centrifugal pump 11 which,in turn, communicates with a receiver 12 of the heat-transfer fluid.Said refrigerating unit or said bank of the thermoelectric generators Iis likewise connected to an automatic system 13 for regulating thetemperature of the heat-transfer fluid. The automatic system 13comprises temperature pickups, driving stages, amplifiers and powerunits; (not shown). The system 13 is capable of maintaining thetemperature of the heat-transfer fluid exactly at a prerequisite level.

The device of the present invention functions as follows (FIG. 3). Toperform the hypothermy of, say, the human brain the patient's head isplaced within the receiver 12 of the heattransfer fluid and onto a restM whereupon the device is brought close to the head. A specified gapbetween the device and the patient's head is provided due to thepresence of the projections 6 located on the inner surface of the deviceand a holder 15 which allows the device to be set in any position withrespect to the patients head. The device is articulated to said holder15 by means ofajoint 16.

The aforesaid pump is intended to deliver the heat-transfer fluid viathe connecting hose to the source it) and further on through the hose 4to the hollow elements, i.e. the tubes 1, wherefrom the heat-transferfluid is distributed as jets from the openings onto the surface of thepatient's body to be treated, preferably at right angles thereto, thefluid having a preset temperature and being fed at a necessary pressure.The used heat-transfer fluid is passed through a strainer 17 located inthe receiver 12 of the heat-transfer fluid and passes to the centrifugalpump 11 which delivers it to the heat-exchanger or the bank of thethermoelectric generators where the heattransfer fluid is cooled (orheated), whereupon the entire working cycle is repeated.

The advantages of the device, according to the invention, are asfollows.

The proposed device is capable of attaining a high rate of cooling orheating (up to 2 C. per 5 min.) of the whole body or a part thereof,e.g. the cerebral cortex, the treatment being effected through thecommon integument of the body, the temperature of the rest of the bodybeing maintained within the safe limits of+32 to +35 C.

The design of the present device enables the surface under treatment tobe under visual observance, gives a free access thereto and makespossible the application of hypothermy at. any position assumed by thepatient's body or the part thereof being treated.

An effective heat-exchangeprocess by the proposed device results in lowpersistence of both the cooling and the heating procedures which makesit possible to provide a reliable automatic stepless regulation of bothprocesses through following a preset programme, a quick transition fromcooling to heating and vice versa as well as a prolonged retention ofthe temperature at a preset hypothermic level.

Moreover, the application of the present device for obtaining hypothermythrough the tegminal tissues of the human body when performing surgicaloperations involving the arrest of blood circulation, needs no donor' sblood or blood substitutes, and cuts the postoperative period of ahospitalization term by 10 to 12 days.

Though this invention has been described hereinbefore with reference tothe preferable embodiment thereof, it will be understood that minorchanges and modifications may be made without departing from the spiritand scope of the invention, as will be readily understood by thoseskilled in the art.

We claim:

l. A device for applying selective and general hypothermy to andreheating of a human or animal body through the common integumentsthereof, said device comprising: a plurality of spaced hollow elementshaving a collective shape corresponding to that of the body surface tobe treated, a header coupled to said hollow elements, means to supply aheattransfer medium to said header and thereby to said elements, saidelements having inner openings facing the body surface to be treated andincluding internal projections for contact with the surface to betreated to position said openings above said surface for allowing theheat-transfer medium to emerge from said hollow elements in uniformlydistributed jets directly acting on the body surface being treated atapproximately right angles thereto, a receiver for receiving andcollecting the medium after contact thereof with said surface, means forrecirculating the collected medium to said header from said receiver,and means between the latter recirculating means and said header forvarying the temperature of the medium in the course of recirculationthereof from said receiver to said header.

2. A device as claimed in claim 1 comprising filter means in saidreceiver for cleaning the collected medium of impurities.

3. A device as claim in claim 1 wherein said recirculating means is apump and whereinsaid means for varying the temperature of the mediumcomprises a heat exchanger between said pump and header and automaticcontrol means coupled to the heat exchanger to automatically regulatethe temperature of the medium supplied to the header in accordance withthe actual temperature of the body.

4. A device as claimed in claim 1 wherein said hollow elements aresufficiently spaced such that gaps are formed therebetween to providequick and free evacuation of the spent medium therethrough as well asvisual control of the surface being treated and free access thereto.

5. A device as claimed in claim 1 wherein said receiver for theheat-transfer medium includes means adapted to be arranged under thebody being treated.

6. A device as claimed in claim 1 wherein said means for varying thetemperature of the medium comprises semi conducting thermoelectricalgenerators.

